Health TrialsbyHealthPanel

Vagina-View Safety and Imaging Feasibility

ConditionVaginal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Health Network, Toronto

About this trial

This prospective, single-arm feasibility study evaluates the use of the Vagina-View (VV) device to guide the placement of a multichannel applicator (MCA) during vaginal brachytherapy. The study aims to determine whether the device can accurately visualize vaginal mucosal tumor involvement and improve the precision of MCA placement. By reducing the need for MRI guidance, the VV device may offer a less resource-intensive approach while minimizing radiation exposure to healthy vaginal tissue and potentially reducing treatment-related side effects. VV will not be used for participants' treatment planning and delivery. Only images will be taken with VV. The primary objective is to demonstrate the feasibility and positional accuracy of using the VV device for MCA placement.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Any patient with gynecological cancer who is planned to receive MRI-guided intravaginal brachytherapy with an MCA applicator.

Able to receive and understand verbal and written information regarding study and able to give written informed consent

Disqualifiers

Patient receiving brachytherapy with a different brachytherapy device.

Patient with contraindications to MRI.

Trial design

Design model

Single group

Treatments tested in this trial

  • Vagina-View (VV) device

    Device

    Placement of the VV applicator intravaginally during MCA brachytherapy. The VV is anticipated to be in the vagina for approximately 10-15 minutes. VV placement would be repeated for imaging scans only at each fraction of MCA brachytherapy (between 3 and 5 fractions in total). VV will not be used for participants' treatment planning and delivery. Only images will be taken with VV.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Vagina-View (VV) deviceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number and Location of Mucosal Disease Sites Identified Using the Vagina-View Grid Coordinate System

Vaginal mucosal disease sites visualized with the Vagina-View (VV) device while in situ will be recorded and reported. Disease location will be documented using the VV grid coordinate system.

Time frame
1 month

Secondary outcomes

1

Treatment device positioning versus MRI visualization

Delineation of mucosal disease visible on endoscopic imaging or in relation to the VV grid coordinates + Delineation of disease visible on MRI. Measured in mm

Time frame
1 month
2

Extent of disease using optical visualization versus MRI

Calculation of contour overlap using DICE coefficient

Time frame
1 month
3

Extent of disease using optical visualization versus MRI

Calculation of contour overlap using average difference in distance in mm

Time frame
1 month
4

Mean Difference in Dosimetric Planning Parameters Between Vagina-View and Standard-of-Care Brachytherapy Plans

Dosimetric metrics derived from brachytherapy treatment plans generated using the VV device and SOC MCA with MRI guidance will be reported and compared using appropriate statistical methods.

Time frame
1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov
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